CompletedNot Applicable

Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2

France6 participantsStarted 2014-10-20

Plain-language summary

The investigators propose to conduct a comparative pilot cognitive and psychiatric profiles of 10 patients Facio-Scapulo-Humeral Dystrophy (= FHSD) type 1 and 10 patients with type 2 FSHD study. For this, the investigators relied on observational components: FSHD2 patients appear more often present with psychiatric comorbidities and seem to have lower cognitive performance compared to FSHD1 patients. This was confirmed by a preliminary study on a small sample population of patients. It seems to exist mainly executive dysfunction associated with attention disorders in patients FSHD2. Moreover, their performance in IQ tests would be low in relation to their socio-educational and compared with patients FSHD1 level.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age ≥ 18 years and \<75 years * FSHD patients 1 or 2 with genetic confirmation Exclusion Criteria: * Phosphokinase creatine level \> 5 time of the normal * Patient as medical history : * A history or active neurological disease likely to interfere with the interpretation of results * a history of head trauma * an infectious disease, hormonal, inflammatory or some deficiency may induce cognitive and / or psychiatric troubles * Patient with cons-indication for performing a brain MRI * Pregnant, parturient and lactating (producing a serum pregnancy test)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Montgomery and Asberg Depression Rating Scale

Timeframe: One time at the inclusion

Hamilton Depression Rating Scale

Timeframe: One time at the inclusion

Hamilton Anxiety Rating Scale

Timeframe: One time at the inclusion

Quick inventory of depressive symptomatology Self report

Timeframe: One time at the inclusion

Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form

Timeframe: One time at the inclusion

Mini Mental Status Evaluation

Timeframe: One time at the inclusion

Wechsler Adult Intelligence Scale

Timeframe: One time at the inclusion

Trial details

NCT IDNCT02032979

SponsorCentre Hospitalier Universitaire de Nice

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-07-01

View on ClinicalTrials.gov More Muscular Dystrophy, Facioscapulohumeral trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Montgomery and Asberg Depression Rating Scale

Timeframe: One time at the inclusion

Hamilton Depression Rating Scale

Timeframe: One time at the inclusion

Hamilton Anxiety Rating Scale

Timeframe: One time at the inclusion

Quick inventory of depressive symptomatology Self report

Timeframe: One time at the inclusion

Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form

Timeframe: One time at the inclusion

Mini Mental Status Evaluation

Timeframe: One time at the inclusion

Wechsler Adult Intelligence Scale

Timeframe: One time at the inclusion